Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse replaced the front end board as the iabp unit was not recognizing the original front end board.It was noted that the new front end board has a new ecg jack housing.Subsequently, the fse calibrated the 30 psi regulator then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.The full name of the event site in block e1 was shortened due to field character limit; the full name is (b)(6).
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